If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

The European Free Sales Certificate (FSC) is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his authorized representative (EC REP) has his registered place of business.

For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.